Chemotherapy Products and Procedures

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Chapter 14Chemotherapy Products

and Procedures

2012 Paradigm Publishing

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Learning Objectives Gain an awareness of the historical roots of using

chemotherapy to treat cancer. Identify the special situations and actions that must be

considered when preparing chemotherapy. Identify the USP Chapter <797> procedures that must be

performed when compounding chemotherapy. Demonstrate correct technique in preparing chemotherapy

CSPs.


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Topics Learning Objectives Introduction Common Chemotherapy Drug Categories Properties of Chemotherapy CSPs Compounding of Chemotherapy CSPs Handling Risks for Chemotherapy Training for Chemotherapy Preparers Administration of Chemotherapy CSPs Administration Risks of Chemotherapy USP Chapter <797> Guidelines for Chemotherapy Preparati

on Understand the Resources and Supplies Preview the Lab Procedure Chapter Summary


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Introduction Chemotherapy is primarily used to treat cancer

primary chemotherapy is prescribed with the intention of curing the patient

adjuvant chemotherapy is prescribed as a follow-up treatment to the removal or reduction of a tumor by surgery and is commonly prescribed after surgical procedures, such as a mastectomy in breast cancer, or an oopharectomy in ovarian cancer

palliative chemotherapy is sometimes prescribed as a treatment for incurable cancers


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Introduction…/2

There are a limited number of other conditions for which chemotherapy may be prescribed, including autoimmune disorders


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Common Chemotherapy Drug Categories

The prescriber orders the chemotherapy treatment proven to be most effective against the patient’s specific type, location, and stage of cancerother factors such as the patient’s age, kidney function,

liver function, and ability to tolerate the side effects of the specific chemotherapy treatment are considered when choosing the most appropriate chemotherapy


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Common Chemotherapy Drug Categories…/2

Alkylating agents are drugs that bind to specific DNA cells and stop their replication

Antimetabolite medications are drugs that block the use of nutrients essential to the growth of cancer cells

Antimicrotubule agents are drugs that interfere with cell formation and growth

Chemotherapeutic antibiotics, also known as antitumor antibiotics, are special types of antibiotics formulated to inhibit RNA synthesis as well as slow down or prevent cell mitosis


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Hormone therapy employs drugs that interfere with the growth of certain proteins within cancer cells, thereby inhibiting their growth or replicationthe use of hormones or their antagonists slows the growth

of hormone-dependent tumors Mitotic inhibitors are drugs that inhibit the process of

cell mitosis Targeted therapy is a sophisticated type of

chemotherapy that targets the specific molecular features of certain cancer cells to inhibit their growth


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Topoisomerase inhibitors disrupt DNA repair functions within the cell, thereby inhibiting the growth and replication of cancer cells

Many cancer treatment regimens incorporate treatment with a combination of chemical agents, hormone therapies, surgery, and radiation


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Properties of Chemotherapy CSPs

Chemotherapy CSPs are typically LVP solutions made from a standard, premade IV base solution into which a chemotherapeutic medication is injected during sterile compounding procedurescytotoxic medications are drugs that poison or otherwise

destroy cancer cells so that they are not able to grow or reproduce

antineoplastic medications are drugs that reduce or prevent the growth of cancer cells


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Properties of Chemotherapy CSPs…/2

In addition to killing cancer cells, many chemotherapeutic agents are also toxic to healthy cellsmay have properties that make them carcinogenic,

teratogenic, mutagenic, or immunosuppressivemay also have numerous side effectsbone marrow suppression is a potentially dangerous type

of toxicity that may lead to an increased risk of bleeding or infections, such as septicemia

some chemotherapy drugs are vesicants, which may cause blisters or tissue necrosis


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Compounding of Chemotherapy CSPs

Due to the dangerous nature of these hazardous drugs, many facilities take special precautions prior to the compounding process to avoid chemotherapy-related medication errors


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Compounding of Chemotherapy CSPs…/2

Chemotherapy Medication Orders Many facilities use

preprinted chemotherapy medication order forms


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Chemotherapy Medication Orders…continued In addition to the chemotherapy CSP, chemotherapy

medication orders generally prescribe a number of other CSPs that are not hazardous drugsthe orders for these CSPs are often called chemotherapy

support orders, or chemotherapy comfort ordersthis often includes orders for LVP hydration preparations,

IVPB antiemetics, and medications for pain and anxiety


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Dosage Calculations Methods Body surface area (BSA) is an estimated measurement

of the human body based on the patient’s height and weight and is expressed in meters squared (m2)the prescriber determines a patient’s BSA using a nomogramonce the desired dose has been determined, additional

dosage calculations—using dimensional analysis and either the basic formula calculation or the ratio and proportion calculation—are required to determine the amount of medication to draw up for the CSP


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Chemotherapy Compounding Environment Hazardous drug chemotherapy should be prepared in

a vertical laminar airflow hooda type of hood that offers added protection to the worker

and the environment when working with these toxic chemicals


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Chemotherapy Compounding Environment…continued A biological safety cabinet

(BSC) is a special hood that has several features specifically designed to protect sterile compounding personnelshould be located in a

negative-pressure clean room


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Chemotherapy Compounding Environment…continued Another type of hood used

to prepare chemotherapy is the compounding aseptic containment isolator (CACI)is a completely enclosed

system accessed through the use of a fixed pair of gloves at the front of the hood


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Surface Sampling of BSC or CACI No matter which type of primary engineering control

(PEC) is used during the compounding of chemotherapy CSPs, quality control measures must be implemented to ensure that the hood offers adequate containment for the toxic chemicalsthe work area surrounding the BSC or CACI must undergo

surface sampling at least every six months


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Handling Risks for Chemotherapy

Safety Regulations OSHA regulations require

maintenance and easy access to material safety data sheets (MSDSs) for all chemotherapy drugs


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Handling Risks for Chemotherapy…/2

Safety Regulations…continued OSHA recommends

facilities have a chemotherapy spill kit readily available in areas where chemotherapy is compounded or administered


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Storage and Labeling of Chemotherapeutic Agents With regard to pharmacies, chemotherapy drugs

must be stored separately from other pharmacy inventory

Some chemotherapy drug manufacturers utilize tall-man lettering, also known as mixed-case lettering, to draw attention to chemotherapy drug names that look or sound similar


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Transport and Disposal of Chemotherapeutic Agents Transport companies must follow procedures

designed to properly package and transport chemotherapy drugs to protect handlers from breakage or spillage of the containersin addition, those personnel who stock pharmacy shelves

must wear special, extra-thick chemotherapy gloves when handling drug vials


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Transport and Disposal of Chemotherapeutic Agents…continued Chemotherapy waste containers

must be affixed with hazardous drug warning labels

Chemotherapy waste must be incinerated at a high temperature to avoid human and environmental contamination


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Your Turn


1) This type of chemotherapy is prescribed with the intention of curing the patient.a. immunosuppressiveb. palliativec. adjuvantd. primary

2) Some chemotherapy drug manufacturers utilize this type of lettering to draw attention to chemotherapy drug names that look or sound similar.a. italicsb. capitalsc. tall-mand. coloration

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Training for Chemotherapy Preparers

USP Chapter <797> mandates that, at a minimum, sterile compounding personnel preparing chemotherapy CSPs must be expertly trained and must undergo two types of evaluation: a written exam and a laboratory procedure exam

Compounding personnel with reproductive capabilities should sign a statement of understanding regarding the potential teratogenic risks of handling hazardous drugs


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Administration of Chemotherapy CSPs

Most chemotherapy is administered in a hospital or clinic setting by a nurse who is specially trained in the parenteral administration of hazardous drugsadministered intravenously

via an IV pump programmed to administer the medication at a controlled IV flow rate


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Administration of Chemotherapy CSPs…/2

Administration time for one session typically requires a minimum of several hours, and chemotherapy treatment may last for a year or more, with monthly cycles lasting approximately one week

CSPs are generally administered into a large vein in the chest, most often the subclavian veinaccomplished by placing a central venous catheter (CVC)

into the vein during a minor surgical procedure


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Administration Risks of Chemotherapy

Complications may include:nosocomial infectionallergic reaction (including anaphylaxis)phlebitistissuingembolismextravasationcellulitisStevens-Johnson syndromenephrotoxicity


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Administration Risks of Chemotherapy…/2

Chemotherapy medications may also produce a number of adverse reactions and side effects

Patients on chemotherapy must be closely monitored to ensure that the medication is not creating unexpected damage to the patient’s vital organs


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USP Chapter <797> Guidelines forChemotherapy Preparation

As well as defining the appropriate environment in which chemotherapy CSPs should be prepared, USP Chapter <797> also details the type of equipment that must be used by sterile compounders and the special training requirements for healthcare personnel who compound chemotherapy CSPsthese procedures are reinforced in each facility’s P&P

manual


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Understand the Resources and Supplies

Essential Supplies Most chemotherapy sterile compounding procedures

require the same essential supply items to be available for use in both the anteroom and the clean room


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Understand the Resources and Supplies…/2

Procedure-Specific Supplies Chemotherapy Equipment,

Supplies, and Special Proceduresa chemotherapy gown is a

sterile, single-use gown made of a thick, woven material that repels fluid


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Procedure-Specific Supplies…continued Chemotherapy Equipment,

Supplies, and Special Procedures…continuedchemotherapy gloves are

sterile nitrile gloves that are thicker than regular sterile gloves


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Procedure-Specific Supplies…continued Chemotherapy Equipment,

Supplies, and Special Procedures…continuedchemotherapy preparation

requires the use of special eye protection

a chemotherapy compounding mat is a thin mat, approximately 12” × 18”


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Understand the Resources and Supplies…/5Procedure-Specific Supplies…continued Chemotherapy Equipment, Supplies,

and Special Procedures…continueda chemotherapy dispensing pin is a

small plastic device with a spike at one end and a Luer-lock syringe adaptor at the other end

air may be safely vented from the chemotherapy drug vial without fear of aerosolization


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Understand the Resources and Supplies…/6Procedure-Specific Supplies…continued Chemotherapy Equipment,

Supplies, and Special Procedures…continueda closed-system transfer device

(CSTD) is a small, disposable device that may be used to safely draw fluid from a vial into a syringe, or to inject fluid from a syringe into an IV or IVPB


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and Special Procedures…continuedthe IV base solution bag is the same

type of bag used for other LVPs: a bag with a tail injection port

sterile, nonvented IV tubing is attached to the LVP bag to administer the chemotherapy CSP to the patient

CSPs require auxiliary warning labels


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and Special Procedures…continuedchemotherapy sharps containers are

similar to regular sharps containers in shape and function, and generally bright yellow in color.


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Understand the Resources and Supplies…/9Procedure-Specific Supplies…continued BSC

a Class I BSC provides protection for the worker but does not provide a suitable HEPA-filtered, ISO Class 5 environment to prepare CSPs

a Class II BSC provides protection for the worker and an ISO Class 5 environment suitable for chemotherapy sterile compounding

a Class III BSC is designed for the manufacture of microbiological agents and provides maximum worker protection


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Understand the Resources and Supplies…/10Procedure-Specific Supplies…continued Components of the BSC

air intake grillsblowerglass shieldexhaust HEPA filterhood HEPA filterprefilterwork surface


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Understand the Resources and Supplies…/11Procedure-Specific Supplies…continued Cleaning the BSC

cleaning procedures for the BSC are significantly different from those procedures used for cleaning a standard horizontal laminar airflow hood

Special Considerations for Suppliescompounding of chemotherapy CSPs has unique

requirements for the placement, selection, and handling of supply items


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Critical Sites of Essential Suppliesand Chemotherapy Supplies

Before beginning preparatory procedures in the anteroom or clean room, the IV technician must recall the critical sites of the suppliesidentifying the critical site of each supply item helps you to

determine the proper procedure for handling the supply item once you have entered the clean room and begin to work in the hood


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Preview the Lab Procedure

Anteroom Preparatory Procedures

Clean Room Preparatory Procedures

Chemotherapy CSP Compounding Procedure


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Your Turn


3) Chemotherapy CSPs are generally administered into a large vein in this body part.a. abdomenb. legc. chestd. arm

4) Chemotherapy CSPs require this type of warning label. a. auxiliaryb. best-beforec. throw-awayd. refrigerate-for

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Health & Medicine

Chemotherapy Products and Procedures